EPPrincipal Specialist, Regulatory Affairs
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Job Summary
JOB DESCRIPTION:
MAIN PURPOSE OF THE ROLE
Specialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs.
Ability to execute highly complex or specialized projects.
Adapts precedent and may make significant departures from traditional approaches to develop solutions.
MAIN RESPONSIBILITIES
As the Specialist in the Regulatory Affairs Sub-Function considered as highly experienced and knowledgeable resource within
the organization in directing development of product registration submission progress reports supplements amendments or
periodic experience reports.
Interacts with regulatory agency to expedite approval of pending registration.
Serves as regulatory liaison throughout product lifecycle.
Participates in some of the following: product plan development and implementation regulatory strategy risk management
chemistry manufacturing control (CMC).
Ensures timely approval of new drugs biologics or medical devices and continued approval of marketed products.
Serves as regulatory representative to marketing research teams and regulatory agencies.
Advises development and/or marketing teams on manufacturing changes line extensions technical labeling appropriate
regulations and interpretations.
QUALIFICATIONS
Education
Associates Degree ( 13 years)
Experience/Background
Minimum 7 years
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
MD Medical Devices
LOCATION:
Japan > Tokyo : Hamarikyu Park Side Place 9F 17F 5-6-10TsukijiChuo-ku
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Staff IC
Key Skills
- Athletics
- Corporate Banking
- Dreamweaver
- Facilities
- IT Support
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
